Table 2

Primary and Secondary endpoints
Primary and Secondary endpoints
Type Description
Primary Change from baseline to Day 36 in 6-hour HBT total hydrogen production;
Primary Change from baseline (6-hour timepoint) to Day 36 (6-hour timepoint) in lactose intolerance symptom assessment total score during lactose challenge.
Primary-Safety Adverse events (AEs), Vital signs, Clincal laboratory results, physical examinations
Secondary Change from baseline to Day 66 in 6-hour HBT total hydrogen production
Secondary Change from baseline (6-hour timepoint) to Day 66 (6-hour timepoint) in lactose intolerance symptom assessment total score during lactose challenge
Secondary Change from baseline (6-hour timepoint) to Day 36 (6-hour timepoint) in individual lactose intolerance symptom assessment categories (ie, abdominal pain, bloating, flatulence, diarrhea, and abdominal cramping)
Secondary Change from baseline (6-hour timepoint) to Day 66 (6-hour timepoint) in individual lactose intolerance symptom assessment categories (ie, abdominal pain, bloating, flatulence, diarrhea, and abdominal cramping)
Secondary Responder analysis, comparing RP-G28 group to placebo group, based on numbers (percent) of subjects achieving a 50% reduction in symptoms (total and individual scores, 6 hours) at Day 36 compared with the baseline lactose challenge and at Day 66 compared with the baseline lactose challenge
Secondary Patient Global Assessment

Savaiano et al.

Savaiano et al. Nutrition Journal 2013 12:160   doi:10.1186/1475-2891-12-160

Open Data